Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

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The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8. [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures
:

The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers. [ Time Frame: 8 weeks of treatment ]

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Men and women, 18 years of age and older

Signed and dated informed consent to participate before any study-related procedures are performed

Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed

A Crohn's Disease Activity Index (CDAI) score of 220 to 450 inclusive

Female subjects who are not surgically sterile or postmenopausal must use medically acceptable methods of birth control during and for 30 days after the treatment period.

A stool sample must be taken at screening and analyzed by a local laboratory for enteric pathogens, pathogenic ova and parasites, and Clostridium difficile toxin, and reported negative prior to randomization.

C-reactive protein value must be 1.0 mg/dL or more, unless there are obvious manifestations of currently active Crohn's disease such as positive observations on endoscopy, other positive indications by laboratory test results, or the subject has had a previous intestinal resection for Crohn's disease.

Bowel obstruction or any condition that may predispose to its development, intestinal perforation, or significant gastrointestinal hemorrhage

Current ileostomy or colostomy or extensive external fistulization (more than 3 external fistulae which are expressible with gentle compression)

Expected to require surgical therapy for Crohn's disease or Crohn's disease related complications within 12 weeks of screening. If an abscess is present, it should be drained at least 3 weeks before pre-screening

History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state

Known substance abuse in the previous 2 years

Nursing mothers or pregnant women

Use of native GLP-2, growth hormone, or growth factors within 3 months of signing informed consent

Use of any of the prior or concomitant medications described in section 5.4, except as specified

Known hypersensitivity to any of the active or inactive constituents of ALX-0600